What is EGFR?

EGFR stands for epidermal growth factor receptor. This is a protein found on cells throughout the body such as those in the lungs, skin, and gastrointestinal tract. When another type of protein called epidermal growth factor attaches to the epidermal growth factor receptor, a variety of changes in the cell occurs. These changes lead to cell growth whether the cells are normal or cancerous.

What does EGFR+ NSCLC mean?

If your cancer test (biopsy) is positive for an EGFR mutation, it means the tumor has a change, also known as a mutation, in a section of its DNA. This mutated DNA allows cancer cells to grow and spread.

How do I know if my NSCLC is EGFR+?

Your doctor will need a sample of tissue from your tumor. Often, the same sample that was looked at to determine that you had NSCLC is used for this test. The tumor sample will be sent to a pathology lab, where it will be examined and the results will show if the tumor is EGFR+ or negative.

How does IRESSA work?

IRESSA attaches itself to certain abnormal types of the EGFR protein in your lung cancer cells. By doing so, it has been shown to slow down the growth of these cells and may help reduce the size of your tumors.

How well does IRESSA work?

As checked by independent doctors, tumors shrank in 50% of people, and the median time before cancer got worse was 6 months. (Within a range of: 41% to 59% of people; 5.6 to 11.1 months)

As checked by the study’s doctors, tumors shrank in 70% of people, and the median time before cancer got worse was 8.3 months. (Within a range of: 61% to 78% of people; 7.6 to 11.3 months)

IRESSA may extend the time before the cancer gets worse. In a different study, after the results were reported, physicians got more insights from a second analysis of the data. The second analysis suggested that among the people who had the EGFR mutation in their metastatic NSCLC tumors:

On 250 mg orally once-daily IRESSA, there was a median 10.9 months of progression-free survival

On up to 6 cycles of carboplatin/paclitaxel chemotherapy, there was a median 7.4 months of progression-free survival

What should I tell my doctor before starting IRESSA?

Before taking IRESSA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems

ever had liver problems

have vision or eye problems

are pregnant or plan to become pregnant. IRESSA can harm your unborn baby

Females who are able to become pregnant should use an effective method of birth control during treatment with IRESSA and for at least 2 weeks after the last dose of IRESSA. You should avoid becoming pregnant during treatment with IRESSA

Tell your healthcare provider right away if you become pregnant during treatment with IRESSA

are breastfeeding or plan to breastfeed. It is not known if IRESSA passes into your breast milk. Do not breastfeed during treatment with IRESSA. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. If you take a proton pump inhibitor (PPI), H2 blocker, or an antacid medicine, talk to your healthcare provider about the best time to take it during treatment with IRESSA. If you take a blood thinner called warfarin, your healthcare provider should do blood tests regularly to check how fast your blood clots, during treatment with IRESSA

What are the possible side effects of IRESSA?

IRESSA may cause serious side effects, including:

Lung or breathing problems. IRESSA may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever

Liver problems. IRESSA may cause inflammation of the liver that may lead to death. Tell your healthcare provider right away if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, light-colored bowel movements (stools), decreased appetite, or pain on the right side of your stomach (abdomen). Your healthcare provider will do blood tests to check your liver function during your treatment with IRESSA

A tear in the wall of your stomach or intestines (perforation). Get emergency medical help right away if you have severe stomach (abdomen) pain

Diarrhea. Diarrhea is common with IRESSA and can sometimes be severe. Tell your healthcare provider right away if you have severe diarrhea or diarrhea that will not go away

Skin reactions. Skin redness, rash, itching, and acne are common with IRESSA. This may occur on any part of your body. Get medical help right away if you develop severe skin reactions such as peeling or blistering of your skin

Common side effects of IRESSA

Most commonly, there are two kinds of side effects that people may experience when taking IRESSA: diarrhea (29% of people) and skin reactions (47% of people) such as rash, acne, and itchy, dry skin. Although not common, some people may experience severe diarrhea or skin reactions.

Other possible side effects

Other possible side effects include lung or breathing problems, liver problems, a tear in the wall of the stomach or intestines, and eye problems.

IRESSA may cause fertility problems in females. Talk to your healthcare provider if you plan to become pregnant.

What should I do if I experience any side effects?

You’re not alone in your IRESSA therapy. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IRESSA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manage daily life with metastatic EGFR+ NSCLC

Important Safety Information

Before taking IRESSA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems

ever had liver problems

have vision or eye problems

are pregnant or plan to become pregnant. IRESSA can harm your unborn baby.

Females who are able to become pregnant should use an effective method of birth control during treatment with IRESSA and for at least 2 weeks after the last dose of IRESSA. You should avoid becoming pregnant during treatment with IRESSA.

Tell your healthcare provider right away if you become pregnant during treatment with IRESSA.

are breastfeeding or plan to breastfeed. It is not known if IRESSA passes into your breast milk. Do not breastfeed during treatment with IRESSA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

If you take a proton pump inhibitor (PPI), H2 blocker, or an antacid medicine, talk to your healthcare provider about the best time to take it during treatment with IRESSA.

If you take a blood thinner called warfarin, your healthcare provider should do blood tests regularly to check how fast your blood clots, during treatment with IRESSA.

What are the possible side effects of IRESSA?

IRESSA may cause serious side effects, including:

Lung or breathing problems. IRESSA may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.

Liver problems. IRESSA may cause inflammation of the liver that may lead to death. Tell your healthcare provider right away if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, light-colored bowel movements (stools), decreased appetite, or pain on the right side of your stomach (abdomen).Your healthcare provider will do blood tests to check your liver function during your treatment with IRESSA.

A tear in the wall of your stomach or intestines (perforation). Get emergency medical help right away if you have severe stomach (abdomen) pain.

Diarrhea. Diarrhea is common with IRESSA and can sometimes be severe. Tell your healthcare provider right away if you have severe diarrhea or diarrhea that will not go away.

Skin reactions. Skin redness, rash, itching, and acne are common with IRESSA. This may occur on any part of your body. Get medical help right away if you develop severe skin reactions such as peeling or blistering of your skin.

IRESSA may cause fertility problems in females. Talk to your healthcare provider if you plan to become pregnant.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IRESSA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is IRESSA?

IRESSA is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and:

that have certain types of abnormal epidermal growth factor receptor (EGFR) genes, and

who have not had previous treatment for cancer

Your healthcare provider will perform a test to make sure that IRESSA is right for you.

Important Safety Information

Before taking IRESSA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems

ever had liver problems

have vision or eye problems

are pregnant or plan to become pregnant. IRESSA can harm your unborn baby.

Females who are able to become pregnant should use an effective method of birth control during treatment with IRESSA and for at least 2 weeks after the last dose of IRESSA. You should avoid becoming pregnant during treatment with IRESSA.

Tell your healthcare provider right away if you become pregnant during treatment with IRESSA.

are breastfeeding or plan to breastfeed. It is not known if IRESSA passes into your breast milk. Do not breastfeed during treatment with IRESSA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

If you take a proton pump inhibitor (PPI), H2 blocker, or an antacid medicine, talk to your healthcare provider about the best time to take it during treatment with IRESSA.

If you take a blood thinner called warfarin, your healthcare provider should do blood tests regularly to check how fast your blood clots, during treatment with IRESSA.

What are the possible side effects of IRESSA?

IRESSA may cause serious side effects, including:

Lung or breathing problems. IRESSA may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.

Liver problems. IRESSA may cause inflammation of the liver that may lead to death. Tell your healthcare provider right away if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, light-colored bowel movements (stools), decreased appetite, or pain on the right side of your stomach (abdomen).Your healthcare provider will do blood tests to check your liver function during your treatment with IRESSA.

A tear in the wall of your stomach or intestines (perforation). Get emergency medical help right away if you have severe stomach (abdomen) pain.

Diarrhea. Diarrhea is common with IRESSA and can sometimes be severe. Tell your healthcare provider right away if you have severe diarrhea or diarrhea that will not go away.

Skin reactions. Skin redness, rash, itching, and acne are common with IRESSA. This may occur on any part of your body. Get medical help right away if you develop severe skin reactions such as peeling or blistering of your skin.

IRESSA may cause fertility problems in females. Talk to your healthcare provider if you plan to become pregnant.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IRESSA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

What is IRESSA?

IRESSA is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and:

that have certain types of abnormal epidermal growth factor receptor (EGFR) genes, and

who have not had previous treatment for cancer

Your healthcare provider will perform a test to make sure that IRESSA is right for you.